Generate Biomedicines, Inc.: Q2 FY2026 earnings call

What management said about Q2 FY2026, from the documents filed with the SEC on 6 August 2026: press release. Guidance figures: 1 new, 1 kept. The quarter’s numbers.

Key takeaways

Revenue fell from prior year: Collaboration revenue was $6.3 million, against $10.1 million a year earlier and $7.2 million in the first quarter. Management tied revenue to the Amgen and Novartis research programs. Source
Net loss higher than prior year: Net loss was $67.3 million, against $56.7 million a year earlier and $61.7 million in the first quarter. Net loss per share, basic and diluted, was $(0.52), against $(1.94). Source
SOLAIRIA approvals reach 33 countries: Regulatory approvals for the SOLAIRIA-1 and SOLAIRIA-2 replicate Phase 3 studies in severe asthma now cover 33 of 42 planned countries. Approvals are ongoing. Source
GB-4362 Phase 1 cohort fully enrolled: All patients are enrolled and initial patients are dosed in the first cohort of the GB-4362 Phase 1 study with enfortumab vedotin and pembrolizumab in urothelial cancer. Source
Novartis biologic reaches preclinical stage: Novartis advanced a platform-designed biologic into preclinical development. The company said it is the first time a biologic engineered on an AI-enabled platform has reached this stage. Source
R&D rose on SOLAIRIA trials: R&D expense was $64.3 million, against $59.7 million a year earlier and $57.8 million in the first quarter. Phase 3 spending rose, partly offset by lower external discovery costs. Source
Cash and securities fell to $457.4 million: Cash, equivalents and marketable securities were $457.4 million, against $516.6 million on March 31, 2026. The March figure reflected $369.3 million of net IPO proceeds. Source

“Our team’s focus on execution for our clinical programs and translating our generative biology platform into the next generation of differentiated medicines drove strong progress in the second quarter,”
Mike Nally, chief executive officer of Generate Biomedicines Inc.

Guidance

Area	Period	Figure	Against last quarter
Cash runway Source	Into first half 2028	into the first half of 2028	Kept
Regulatory approvals, SOLAIRIA studies Source	Planned 42-country development program	33 countries of a planned 42-country program	New
GB-5267 first patient dosing Source	2026	in 2026

What changed from last quarter

Guidance kept: Cash runway statement carried forward. The wording now refers to the current operating plan, with the same timing into the first half of 2028. Source
New: Novartis advanced a platform-designed biologic into its preclinical pipeline, which the release describes as the first such biologic from an AI-enabled platform to reach this stage. Source
New: All patients enrolled in the first cohort of the GB-4362 Phase 1 study, with initial patients dosed. The first-quarter release had reported trial sites activated and first dosing expected mid-2026. Source
New: The GB-5267 Phase 1 study, run with Roswell Park, is now recruiting. The first-quarter release had described first dosing as expected in the second half of 2026. Source

Quarterly results and drivers

Revenue fell from prior year: Collaboration revenue was $6.3 million, against $10.1 million a year earlier and $7.2 million in the first quarter. Management tied revenue to the Amgen and Novartis research programs. Source
Net loss higher than prior year: Net loss was $67.3 million, against $56.7 million a year earlier and $61.7 million in the first quarter. Net loss per share, basic and diluted, was $(0.52), against $(1.94). Source
Weighted share count rose: Weighted average basic and diluted shares were 128,240,371, against 32,996,506 a year earlier. Net loss per share for the six months was $(1.41), against $(3.57). Source

GB-0895 in severe asthma and COPD

SOLAIRIA approvals reach 33 countries: Regulatory approvals for the SOLAIRIA-1 and SOLAIRIA-2 replicate Phase 3 studies in severe asthma now cover 33 of 42 planned countries. Approvals are ongoing. Source
Recruitment open in six regions: Recruitment is underway in all six global regions covered by the program: North America, Eastern and Central Europe, Asia, Western Europe, LATAM, and the Middle East, Africa and South Asia. Source
Golukibart name proposed for GB-0895: GB-0895 is an investigational anti-TSLP antibody. The World Health Organization has proposed the international nonproprietary name golukibart for it. Source

“Because our platform is inherently scalable, we can simultaneously advance our internal pipeline, execute on existing collaborations, and enter into additional strategic partnerships.”
Jason Silvers, president and chief financial officer of Generate Biomedicines Inc.

Oncology programs GB-4362 and GB-5267

GB-4362 Phase 1 cohort fully enrolled: All patients are enrolled and initial patients are dosed in the first cohort of the GB-4362 Phase 1 study with enfortumab vedotin and pembrolizumab in urothelial cancer. Source
MMAE neutralizer targets toxicity: GB-4362 is an MMAE neutralizer intended to bind free MMAE after release from the antibody drug conjugate, aiming to reduce treatment-limiting toxicities while preserving ADC activity. Source
GB-5267 CAR T study recruiting: The GB-5267 IL-18 armored MUC16 CAR T Phase 1 study in platinum-resistant ovarian cancer is recruiting. Management expects the first patient to be dosed in 2026. Source

Collaborations and platform

Novartis biologic reaches preclinical stage: Novartis advanced a platform-designed biologic into preclinical development. The company said it is the first time a biologic engineered on an AI-enabled platform has reached this stage. Source
Agentic systems support platform speed: Investments in agentic systems are described as enabling the platform and new pipeline programs to advance with more speed, scale and efficiency. Source
Platform runs as one system: The platform is described as connecting computational design, large-scale experimentation and development as one system, advancing programs across multiple development paths. Source

“That growing opportunity set makes disciplined capital allocation increasingly important as we determine the optimal path for each program and opportunity.”
Jason Silvers, president and chief financial officer of Generate Biomedicines Inc.

Operating costs and stock compensation

R&D rose on SOLAIRIA trials: R&D expense was $64.3 million, against $59.7 million a year earlier and $57.8 million in the first quarter. Phase 3 spending rose, partly offset by lower external discovery costs. Source
G&A rose on stock compensation: G&A expense was $13.6 million, against $10.5 million a year earlier. Noncash stock-based compensation was $8.2 million, against $5.5 million in the prior-year quarter. Source
First-quarter personnel cost increase: The first-quarter release cited higher personnel-related costs in R&D, alongside GB-0895 Phase 3 spending, offset by lower external discovery costs.

Cash, liquidity and capital

Cash and securities fell to $457.4 million: Cash, equivalents and marketable securities were $457.4 million, against $516.6 million on March 31, 2026. The March figure reflected $369.3 million of net IPO proceeds. Source
Operating cash use rose: Net cash used in operating activities was $138.3 million for the six months, against $101.9 million a year earlier. The first-quarter release reported $80.4 million for that quarter. Source
More capital needed for long-term operations: Management said it expects to need additional capital to support long-term operations, beyond the funding covered by its current operating plan. Source
Common shares outstanding rose: Common shares outstanding were 128,269,428 at June 30, 2026, up from 33,116,957 at December 31, 2025. Source

Coming up, as management said on 6 August 2026

COPD Phase 1b poster at ERS: Poster on safety, pharmacokinetic and pharmacodynamic data from the Phase 1b COPD study, scheduled for Sept. 8 at the ERS Congress 2026. Source
Two more ERS posters on asthma: Two additional ERS posters will present complete Phase 1 asthma data and the design of the SOLAIRIA-1 and SOLAIRIA-2 Phase 3 studies. Source
GB-4362 poster at ESMO: A trial-in-progress abstract for GB-4362 is accepted for poster presentation at ESMO Congress 2026, Oct. 23 - 27, in Madrid, Spain. Source

Figures management reported

Figure	Reported
SOLAIRIA regulatory approvals Source	33 countries of a planned 42
GB-4362 Phase 1 cohort enrollment Source	All patients enrolled in first cohort
R&D expense, quarter Source	$64.3 million
FDA Fast Track designation Source	GB-4362, enfortumab vedotin-induced toxicity

Risks management discussed

Financial: Management said the company expects to require additional capital to support long-term operations, beyond the funding in its current operating plan. Source

Earlier plans management reported on

Not stated: Management now says the first patient is expected to be dosed in 2026. The first-quarter release had said second half of 2026. Source
Not stated: Management reports all patients enrolled and initial patients dosed in the first cohort. The first-quarter release had expected first dosing in mid-2026. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.

As filed with the SEC

Open the filing on EDGAR

Generate Biomedicines Inc. Reports Second Quarter 2026 Financial Results and Provides Business Update

SOLAIRIA-1 AND SOLAIRIA-2 Phase 3 studies for GB-0895 (anti-TSLP) in severe asthma continue to advance with recruitment underway across all six global regions

Phase 1b data for GB-0895 in COPD to be presented in a poster at the European Respiratory Society (ERS) Congress 2026 on Sept. 8

All patients enrolled in first cohort of the Phase 1 study for GB-4362 (MMAE neutralizer)

Platform advancements extend across strategic collaborations

Approximately $457.4 million in cash, cash equivalents, and marketable securities as of June 30, 2026

SOMERVILLE, Mass., Aug. 6, 2026 - Generate Biomedicines Inc. (NASDAQ: GENB) (“Generate”) today reported financial results for the second quarter ended June 30, 2026, and highlighted continued progress across its platform, pipeline, and collaborations.

“Our team’s focus on execution for our clinical programs and translating our generative biology platform into the next generation of differentiated medicines drove strong progress in the second quarter,” said Mike Nally, chief executive officer of Generate Biomedicines Inc. “With GB-0895, our global Phase 3 SOLAIRIA studies in severe asthma continue to advance. We dosed the first cohort in our Phase 1 study of our MMAE neutralizer, designed to reduce treatment-limiting toxicities from antibody drug conjugates, and Novartis advanced a biologic designed with our platform into its preclinical pipeline for further development. Together, these milestones demonstrate that we can repeatedly advance programs in our own pipeline and through collaborations.”

“Our platform and continued pipeline progress create optionality,” said Jason Silvers, president and chief financial officer of Generate Biomedicines Inc. “Because our platform is inherently scalable, we can simultaneously advance our internal pipeline, execute on existing collaborations, and enter into additional strategic partnerships. That growing opportunity set makes disciplined capital allocation increasingly important as we determine the optimal path for each program and opportunity.”

Recent Progress

The Generate Platform connects computational design, large-scale experimentation, and development as one system, repeatably advancing programs across multiple development paths. Strategic investments in agentic systems are enabling the platform and our new pipeline programs to advance at increased speed, scale, and efficiency.

In inflammation and immunology, Generate is advancing GB-0895 in severe asthma and COPD. GB-0895 is an investigational anti-TSLP monoclonal antibody for which the World Health Organization has proposed the international nonproprietary name golukibart.

In severe asthma, the global SOLAIRIA-1 and SOLAIRIA-2 replicate Phase 3 studies continue to advance. To date, the studies have received regulatory approvals in 33 countries as part of a planned 42-country development program. Additional approvals are ongoing, and recruitment is underway across all six global regions, including North America; Eastern Europe/Central Europe; Asia; Western Europe; LATAM; and the Middle East, Africa, and South Asia.

At the European Respiratory Society (ERS) Congress 2026, Generate will present three posters on GB-0895 in COPD and severe asthma. The COPD poster will present safety, pharmacokinetic, and pharmacodynamic data from the ongoing Phase 1b study in adults with COPD on Sept. 8. Two additional posters will present complete Phase 1 data in asthma and the design of the ongoing SOLAIRIA-1 and SOLAIRIA-2 replicate Phase 3 studies in severe asthma.

In oncology, Generate is advancing GB-4362, an MMAE neutralizer designed to selectively bind and neutralize circulating free MMAE after it is released from the ADC, with the goal of reducing treatment-limiting MMAE-related toxicities while preserving the intended activity of the ADC. GB-4362 has received FDA Fast Track designation for the prevention and/or reduction of enfortumab vedotin-induced toxicity in patients with urothelial cancer.

All patients were enrolled and initial patients dosed in the first cohort of the Phase 1 study evaluating GB-4362 in combination with enfortumab vedotin and pembrolizumab for locally advanced or metastatic urothelial cancer.

A trial-in-progress abstract for GB-4362 has been accepted for poster presentation at the European Society for Medical Oncology (ESMO) Congress 2026, to be held Oct. 23 - 27, 2026, in Madrid, Spain.

Through a multi-target collaboration, Novartis has advanced a biologic designed with The Generate Platform into its preclinical pipeline for further development. This marks the first time a biologic engineered using an AI-enabled platform has reached this stage.

The Phase 1 study evaluating GB-5267, an IL-18 armored MUC16 CAR T for patients with advanced, platinum-resistant ovarian cancer, which Generate is conducting in collaboration with Roswell Park Comprehensive Cancer Center, is now recruiting. The first patient is expected to be dosed in 2026.

Financial Results

Cash, cash equivalents, and marketable securities were $457.4 million as of June 30, 2026, compared with $516.6 million as of March 31, 2026. Generate believes its existing cash, cash equivalents, and marketable securities will be sufficient to fund its current operating plan into the first half of 2028. Generate expects to require additional capital to support long-term operations.

Revenue for the quarter ended June 30, 2026, was $6.3 million, compared with $10.1 million for the same period in 2025. This revenue reflects developments in the ongoing Amgen and Novartis research programs.

Research and development expenses were $64.3 million for the quarter ended June 30, 2026, compared with $59.7 million for the same period in 2025. The increase was driven primarily by continued investment in the GB-0895 Phase 3 SOLAIRIA clinical trials in severe asthma and was offset by a decrease in external discovery and other program-related costs.

General and administrative expenses were $13.6 million for the quarter ended June 30, 2026, compared with $10.5 million for the same period in 2025. The increase was driven primarily by an increase in stock-based compensation.

Net loss was $67.3 million for the quarter ended June 30, 2026, compared with $56.7 million for the same period in 2025, which includes noncash, stock-based compensation expense of $8.2 million and $5.5 million, respectively.

Net cash used in operating activities was $138.3 million for the six months ended June 30, 2026, compared with $101.9 million for the six months ended June 30, 2025.

About Generate Biomedicines, Inc. Generate (NASDAQ: GENB) is a clinical-stage generative biology company founded at the intersection of machine learning, biological engineering, and medicine, advancing a new era of programmable biology to engineer better medicines for patients, faster. The Generate Platform integrates computational design with large-scale biological experimentation, enabling the creation of novel, optimized therapeutics that address historically undruggable and hard-to-drug targets, as well as known targets in new and more effective ways. The platform has enabled the generation of a broad pipeline of therapies across multiple therapeutic areas and protein-based modalities, addressing health challenges out of reach of traditional approaches. Founded in 2018, Generate is leading a fundamental shift from drug discovery to drug generation. Learn more at www.generatebiomedicines.com or follow us on X, LinkedIn, and YouTube.

Digital Media Disclosure From time to time Generate has used, or expects in the future to use, its investor website (investors.generatebiomedicines.com), the Generate LinkedIn account (linkedin.com/company/generate-biomedicines), and the Generate X account (@generate_biomed) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor the investor website and these social media channels in addition to news releases, SEC filings, public conference calls, and webcasts, as the information posted on them could be material to investors.

Cautionary Note Regarding Forward-Looking Statements This news release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this news release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding Generate’s expectations relating to the advancement of its product candidates; the initiation, timing, progress, and results of its clinical trials, including the upcoming poster presentations of clinical trial data for GB-0895 and GB-4362 and the timing of dosing of the first patient in the Phase 1 clinical trial evaluating GB-5267; the expected enhancements, benefits and; the potential of its generative biology platform; and its expected cash runway. In some cases, the forward-looking statements can be identified by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential,” or “continue,” or the negative of these terms or other similar expressions.

These forward-looking statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, but not limited to, risks and uncertainties related to: Generate’s ability to successfully develop and obtain regulatory approval for its product candidates; the initiation, design, progress, timing, and results of preclinical studies and clinical trials; Generate’s ability to obtain, maintain, and enforce intellectual property protection; Generate’s dependence on third parties for the manufacture and development of its product candidates; the impact of competitive products and technologies; Generate’s ability to replicate positive results from earlier preclinical studies or clinical trials in current or future clinical trials; Generate’s ability to demonstrate that its product candidates are safe and effective for their proposed indications; Generate’s ability to obtain additional capital to fund its operations; and general economic, industry, and market conditions.

Additional information on these and other risks and uncertainties that could affect Generate’s business, financial condition, and results of operations is included in Generate’s filings with the Securities and Exchange Commission, including its Quarterly Reports.

The forward-looking statements in this news release are made as of the date hereof, and Generate undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this news release, except as required by applicable law.

Generate Media Contact Megan McLaughlin pr@generatebiomedicines.com

GENERATE BIOMEDICINES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data) (unaudited)

	As of June 30,	As of December 31,
	2026	2025
Assets
Current assets:
Cash and cash equivalents	$135,359	$121,650
Marketable securities	322,056	99,848
Restricted cash and cash equivalents (VIE)	-	339
Prepaid expenses and other current assets	12,838	12,528
Total current assets	470,253	234,365
Property and equipment, net	27,305	29,151
Operating lease right-of-use assets	55,074	59,860
Other assets	9,058	6,806
Total assets	$561,690	$330,182
Liabilities, convertible preferred stock, non-controlling interest and stockholders’ deficit
Current liabilities:
Accounts payable	$5,653	$3,837
Accrued expenses and other current liabilities	25,196	42,164
Deferred revenue - current	12,168	21,194
Current portion of finance lease liabilities	3,744	4,311
Operating lease liabilities - current	9,875	10,697
Total current liabilities	56,636	82,203
Non-current liabilities:
Warrant to purchase convertible preferred stock	-	1,205
Finance lease liabilities, net of current portion	1,366	2,908
Deferred revenue - non-current	-	4,511
Operating lease liabilities - non-current	47,643	50,610
Other long term liabilities	-	116
Total liabilities	105,645	141,553
Commitments and contingencies (Note 13)
Convertible preferred stock	-	811,826
Non-controlling interest	-	(7,232)
Stockholders’ equity (deficit):
Common stock, par value $0.001; 500,000,000 and 200,456,735 shares authorized as of June 30, 2026 and December 31, 2025 respectively; 128,269,428 and 33,116,957 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively	128	33
Additional paid-in capital	1,261,040	60,189
Accumulated other comprehensive (loss) income	(129)	106
Accumulated deficit	(804,994)	(676,293)
Total stockholders’ equity (deficit)	456,045	(615,965)
Total liabilities, convertible preferred stock, non-controlling interests and stockholders’ equity (deficit)	$561,690	$330,182

(1) Includes related party amounts of $0.1 million as of June 30, 2026, and $0.2 million as of December 31, 2025. See Note 14 for details of related party amounts.

GENERATE BIOMEDICINES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except share and per share data) (unaudited)

	Three Months Ended June 30,		Six Months Ended June 30,
	2026	2025	2026	2025
Collaboration revenue	$6,314	$10,130	$13,538	$18,948
Operating expenses:
Research and development	64,330	59,735	122,142	106,560
General and administrative	13,598	10,545	27,122	20,692
Total operating expenses	77,928	70,280	149,264	127,252
Loss from operations	(71,614)	(60,150)	(135,726)	(108,304)
Other income (expense), net
Change in fair value of convertible preferred stock warrant liability	-	-	(363)	-
Interest expense	(155)	(307)	(337)	(675)
Interest income	4,629	3,789	7,542	8,070
Foreign currency exchange loss	(62)	(30)	(4)	(47)
Total other income (expense), net	4,412	3,452	6,838	7,348
Loss before provision for income taxes	(67,202)	(56,698)	(128,888)	(100,956)
Provision for income taxes	(53)	(44)	(81)	(100)
Net loss	(67,255)	(56,742)	(128,969)	(101,056)
Net loss attributable to non-controlling interests	-	(4,313)	(268)	(6,942)
Net loss attributable to Generate Biomedicines, Inc. stockholders	(67,255)	(52,429)	(128,701)	(94,114)
Convertible preferred stock accrued dividends	-	(11,593)	(7,749)	(23,185)
Net loss attributable to Generate Biomedicines, Inc. common stockholders	$(67,255)	$(64,022)	$(136,450)	$(117,299)
Net loss per share, basic and diluted	$(0.52)	$(1.94)	$(1.41)	$(3.57)
Weighted average common shares outstanding, basic and diluted	128,240,371	32,996,506	96,730,886	32,894,770
Other comprehensive loss:
Net loss	(67,255)	(56,742)	(128,969)	(101,056)
Unrealized loss on marketable securities	(153)	(57)	(235)	(128)
Comprehensive loss	$(67,408)	$(56,799)	$(129,204)	$(101,184)
Comprehensive loss attributable to non-controlling interest	-	(4,313)	(268)	(6,942)
Comprehensive loss attributable to Generate Biomedicines, Inc. stockholders	$(67,408)	$(52,486)	$(128,936)	$(94,242)

(1) Includes related party amounts of $0.1 million for the six months ended June 30, 2026, and $0.1 million and $0.3 million for the three and six months ended June 30, 2025. See Note 14 for details of related party amounts.

(2) Includes related party amounts of $0.1 million and $0.2 million for the three and six months ended June 30, 2026, and $0.1 million and $0.3 million for the three and six months ended June 30, 2025. See Note 14 for details of related party amounts.